Pharmaceutical

CLARENCE, N.Y.–(BUSINESS WIRE)–22nd Century Group, Inc. (NYSE MKT:XXII), a plant biotechnology company that is a leader in tobacco harm reduction, announced today that the Company has launched a new line of Research Cigarettes with varying levels of nicotine. Similar to the Company’s SPECTRUM® brand research cigarettes that are sold only to the National Institute on …

CLARENCE, N.Y.–(BUSINESS WIRE)–22nd Century Group, Inc. (NYSE MKT:XXII),
a plant biotechnology company that is a leader in tobacco harm
reduction, announced today that the Company has launched a new line of
Research Cigarettes with varying levels of nicotine. Similar to the
Company’s SPECTRUM® brand research cigarettes that are sold only to the
National Institute on Drug Abuse (NIDA), 22nd Century’s new proprietary
Research Cigarettes are available directly to accredited scientists,
researchers, universities and governments – worldwide. 22nd Century is
the only company in the world capable of producing tobacco research
cigarettes with varying levels of nicotine that range from 95% less
nicotine than conventional cigarettes (0.5mg/g) to 2X – 3X the nicotine
content of conventional cigarettes (50mg/g).
“At the Society for Research on Nicotine (SRNT) Annual Meeting held in
Chicago in March of this year, the Company received numerous requests
for variable nicotine-level research cigarettes from domestic and
international scientists wishing to conduct nicotine addictive threshold
and smoking cessation studies. 22nd Century is eager to provide
scientists all over the world with the means to conduct their important
smoking research,” explained Dr. Paul Rushton, Vice President of Plant
Biotechnology at 22nd Century Group.
22nd Century custom designs and produces research cigarettes with
precise tobacco blends, nicotine contents, filtration, tar yields, and
even custom taste characteristics for each clinical study according to
the exact specifications required by scientific researchers. With an
approved blend and packaging design, 22nd Century can design, produce
and ship research cigarettes in a matter of weeks, thus speeding up the
often lengthy and cumbersome process researchers currently endure in
order to study behaviors and health risks associated with the use of
tobacco products.
In addition to the significant revenue potential of this initiative, the
Company anticipates that the research generated through the use of 22nd
Century’s Very Low Nicotine research cigarettes will add to the growing
number of peer-reviewed scientific studies that demonstrate the public
health benefits of 22nd Century’s proprietary tobaccos. Such independent
studies formed the backbone of 22nd Century’s December 2015 Modified
Risk Tobacco Product (MRTP) application to the U.S. Food and Drug
Administration (FDA). Indeed, many such scientific studies employing the
Company’s research cigarettes with varying levels of nicotine are funded
by the FDA itself, including the landmark Eric C. Donny, Ph.D. et al.
clinical study that was published in the October 2015 issue of The
New England Journal of Medicine (N
Engl J Med
 2015; 373:1340-1349
). The FDA is also currently
funding – at a cost estimated to exceed $20 million – a follow-up
clinical study seeking the best method to quit smoking: an immediate
reduction in nicotine to non-addictive levels versus a gradual reduction
in nicotine (ClinicalTrials.gov
NCT02139930
). No matter which protocol proves most effective, 22nd
Century is the only company in the world capable of producing the
critical final product: combustible tobacco cigarettes with
non-addictive levels of nicotine.
“Without 22nd Century’s unique ability to provide research cigarettes
with varying nicotine levels, many important research projects would
simply be impossible to conduct,” explained Henry Sicignano III, the
Company’s President and Chief Executive Officer. “Accordingly, due to
the increasing demand for our SPECTRUM® research cigarettes, we felt
compelled to make similar research cigarettes available directly to
scientists around the globe. What’s more, unlike SPECTRUM® cigarettes,
22nd Century’s new research cigarettes will be available in any
configuration and in any style requested by researchers. We expect this
new product line to grow rapidly.”
About 22nd Century Group, Inc.
22nd Century is a plant biotechnology company focused on technology
which allows it to increase or decrease the level of nicotine in tobacco
plants and the level of cannabinoids in cannabis plants through genetic
engineering and plant breeding. The Company’s primary mission is to
reduce the harm caused by smoking. 22nd Century currently owns or
exclusively controls more than 200 issued patents and more than 50
pending patent applications around the world. Visit www.xxiicentury.com
for more information.
Cautionary Note Regarding Forward-Looking Statements:This
press release contains forward-looking information, including all
statements that are not statements of historical fact regarding the
intent, belief or current expectations of 22nd Century Group, Inc., its
directors or its officers with respect to the contents of this press
release, including but not limited to our future revenue expectations.
The words “may,” “would,” “will,” “expect,” “estimate,” “anticipate,”
“believe,” “intend” and similar expressions and variations thereof are
intended to identify forward-looking statements. We cannot guarantee
future results, levels of activity or performance. You should not place
undue reliance on these forward-looking statements, which speak only as
of the date that they were made. These cautionary statements should be
considered with any written or oral forward-looking statements that we
may issue in the future. Except as required by applicable law, including
the securities laws of the United States, we do not intend to update any
of the forward-looking statements to conform these statements to reflect
actual results, later events or circumstances, or to reflect the
occurrence of unanticipated events. You should carefully review and
consider the various disclosures made by us in our annual report on Form
10-K for the fiscal year ended December 31, 2015, filed on February 18,
2016, including the section entitled “Risk Factors,” and our other
reports filed with the U.S. Securities and Exchange Commission which
attempt to advise interested parties of the risks and factors that may
affect our business, financial condition, results of operation and cash
flows. If one or more of these risks or uncertainties materialize, or if
the underlying assumptions prove incorrect, our actual results may vary
materially from those expected or projected.

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